Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium

Phase 1

Completed

• Conditions: Adverse Events; Pharmacokinetic
• Interventions: Drug: ABT-335; Drug: ABT-143; Drug: Rosuvastatin

• Registration Number: NCT00681395
• Lead Sponsor: AstraZeneca

Brief Summary

To evaluate safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-21
• Primary Completion: 2008-08
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-27
• Last Update Posted: 2012-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• General good health
• BMI 19 to 29

Exclusion Criteria

• Currently enrolled in another study
• Females who are pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4	ABT-335	ABT-335 45mg and rosuvastatin 5mg
4	Rosuvastatin	ABT-335 45mg and rosuvastatin 5mg
1	ABT-143	ABT-143 capsules 20/135 mg
2	ABT-335	ABT-335 135mg and rosuvastatin 20mg
2	Rosuvastatin	ABT-335 135mg and rosuvastatin 20mg
3	ABT-143	ABT-143 capsules 5/45mg

Primary Outcome Measures

Name	Time	Method
Adverse event and safety laboratory assessments	7 days
Pharmacokinetic parameters	7 days

Trial Locations

Locations (1)

Site Reference ID/Investigator# 8089; 🇺🇸 Orlando, Florida, United States